Nasal and oral cannula having two capabilities and method of producing same

ABSTRACT

A method of forming a cannula from a cannula mandrel assembly comprising a pair of mouthpiece/nasal mandrels and a mating facepiece mandrel. The facepiece mandrel has a pair of conical holes, in an intermediate section thereof, for receiving a leading end of one mouthpiece/nasal mandrel. The conical holes allow the facepiece mandrel to slide along the mouthpiece/nasal mandrels until the conical holes abut with respective mating tapering conical sections and prevent further sliding movement along the mouthpiece/nasal mandrels. Following assembly, the assembly is heated, at least one coating of a polymeric material is applied thereto and heat from the assembly at least partially cures the polymeric material on the assembly. Following curing, the facepiece mandrel and formed cannula are slide along the mouthpiece/nasal mandrels until the facepiece mandrel and formed cannula are removed therefrom. Lastly, the facepiece mandrel is removed from the formed cannula.

FIELD OF THE INVENTION

This invention relates to a novel cannula which is suitable for use forboth nasal and oral applications and a method of producing the cannulausing disconnectable mandrel parts to form a mold assembly over or onwhich the cannula forming plastics or polymeric material is applied toform the cannula.

BACKGROUND OF THE INVENTION

This invention relates generally to cannulas adapted for both oral andnasal applications for monitoring breathing of a patient, sampling theend tidal CO₂content in the exhaled breath of a patient to determine thepatient's CO₂ blood concentration level, or supplying a treating gas,such as oxygen, to a patient. In addition, the invention relates to amethod of manufacturing a cannula adapted to communicate with both nasalpassages and the mouth of a patient for use in monitoring breathing,sampling end tidal CO₂, supplying a treating gas and is also suitablefor the detection of apnea (the absence of breathing).

Nasal cannulas are commonly used to administer a treating gas, such asoxygen, to humans having respiratory problems. Illustrations of nasalcannulas used for this purpose are found in U.S. Pat. No. 3,802,431, forexample. Nasal cannulas have also been used for inhalation therapy, madepossible by development of inhalation sensors, such as described in U.S.Pat. No. 4,745,925, for example. A nasal cannula can be used to monitorbreathing and for detection of apnea when connected to an inhalationsensor.

Nasal cannulas additionally adapted to communicate with the mouth of apatient to permit administration of a gas or sensing of apnea duringperiods of mouth breathing or nasal blockage are also known.

The present invention relates to a novel cannula and method ofmanufacturing the novel cannula having the ability to communicate withboth nasal cavities as well as the mouth or oral cavity of a patient.This apparatus and method provides, in the preferred embodiment,disconnectable mandrel components which, when assembled with oneanother, form a mold assembly over which a cannula forming polymericmaterial is applied, and which, through the capability of each mandrelcomponent being disconnectable from the other mandrel component(s),facilitates removal of the mandrel components from the formed ormanufactured cannula.

Prior art relating to dipping of a part in a plastisol to create acoating is exemplified by U.S. Pat. Nos. 3,906,071, 4,695,241 and4,800,116, and the disclosures of those references are herebyincorporated by reference.

The closest known prior art is believed to be a sampling cannula soldunder the Salter Labs “One-No. 4001 oral/nasal CO₂ sample line” tradedesignation. This cannula has a pair of prongs or sampling line(s) whicheach communicate with one nostril of the patient and a pair of straightprongs or sampling line(s) which both communicate with the oral or mouthcavity of the patient. A U-shaped wired is glued or otherwise affixed tothe exterior surface of the main body of the cannula but the wireextends only about half the length of each of the oral or mouth cavityprongs or sampling line(s) and along the facepiece of the cannula. Thewire does not extend along the nares. All of the nasal and the oralprongs or sampling line(s) communicate with an internal passage and thuscommunicate with one another so that the cannula can only perform onefunction. The leading free end of the oral or mouth prongs or samplingline(s) can be bent over in front of the teeth of the patient and anyexcess length of the prong(s) or sampling line(s) can be trimmed, asnecessary. This cannula, of Salter Labs, is formed by a cannula mandrelassembly comprising a pair of mouthpiece/nasal mandrels and a facepiecemandrel with an intermediate section of the facepiece mandrel having apair of spaced apart through holes for each receiving a leading end ofone of the mouthpiece/nasal mandrels. Each mouthpiece/nasal mandrel hasa first straight section which forms a straight molded mouthpiece and asecond straight section which forms a molded nare. A bend is formed ineach mouthpiece/nasal mandrel, between the first and second straightsections, to prevent further sliding movement of the facepiece mandrelalong the pair of mouthpiece/nasal mandrels.

SUMMARY OF THE INVENTION

It is an object of the invention to provide a method of manufacturing acannula using an assembly of disconnectable mandrel components overwhich cannula forming plastics or polymeric material is applied.Application of the plastics or polymeric material over the mandrelassembly and subsequent extraction of the mandrel components from oneanother, following sufficient curing of the plastics or polymericmaterial, results in a manufactured cannula with contiguous internalflow paths for sampling the exhaled breath of a patient to detect theend tidal CO₂ in the blood of a patient, sensing patient breathing,and/or supplying a treating gas to the patient.

It is a further object of the invention to provide a multi-part mandrelassembly for forming a cannula which facilitates extraction of each ofthe mandrel assembly components following at least partial curing of thepolymeric material forming the cannula.

Still another object of the invention is to form the main body formingmandrel component as two separate, slightly spaced apart componentswhich remain spaced apart from one another by a gap or void, during thedipping or some other polymeric material application process, so thatthe gap void becomes filled with a plastics or polymeric material toform a wall, septum or barrier which partitions or divides the internalpassage of the cannula into two separate compartments or passageways,one which facilitates either sensing of patient breathing, monitoring ofthe end tidal CO₂ in a patient's blood stream or supplying a treatinggas to the patient, etc., while the other of which also facilitatesanother function, such as, sensing of patient breathing, monitoring ofthe end tidal CO₂ in a patient's blood stream, or supplying a treatinggas to the patient, etc.

Another object of the invention is to produce a cannula having at leastone mouthpiece, and alternatively a pair of side by side mouthpieces,extending from the main body of the cannula to the patient's mouth, thecannula is provided with at least one passageway, or alternatively apair of separate passageways, for supplying a gas to the patient via ademand regulator for example, or sampling a patient's oral exhalationfor monitoring the end tidal CO₂ in a patient's blood stream forinstance, and the at least one mouthpiece, or alternatively the pair ofmouthpieces, has a desired curvature or orientation so that the openingof each mouthpiece is located in or adjacent the mouth or oral cavity ofa patient for detecting or sensing the exhaled breath of the patient.

It is a further object of the invention to provide a nasal cannula whichis continuously able to both supply and withdraw a gas sample from amouth of a breathing patient or a patient which alternates breathingbetween the nose and the mouth and is also able to continuously detectbreathing of a patient who alternates breathing between the nose and themouth.

Yet another object of the invention is to provide a nasal cannula whichis relatively inexpensive to manufacture by a dipping process or someother polymeric material application process as a integral unitarycannula.

Still another object of the invention is to provide a multi-part mandrelassembly for forming a cannula which facilitates extraction of each ofthe mandrel assembly components following at least partial curing thepolymeric material forming the cannula.

The invention also relates to a method of forming a cannula comprisingthe steps of: assembling a cannula mandrel assembly comprising separableengageable parts including a facepiece mandrel and a pair ofmouthpiece/nasal mandrels, an intermediate section of the facepiecemandrel being provided with a pair of spaced apart through holes foreach receiving a remote free end of one of the mouthpiece/nasal mandrelsand allowing the facepiece mandrel to slide along the pair ofmouthpiece/nasal mandrels, and each of the mouthpiece/nasal mandrelshaving a stop feature, with a larger transverse cross section, whichprevents further sliding movement of the facepiece mandrel along thepair of mouthpiece/nasal mandrels and while also avoiding flow of apolymeric material between the facepiece mandrel and themouthpiece/nasal mandrels; heating the cannula mandrel assembly to adesired temperature; providing an uncured polymeric material in flowablestate; applying at least one coating of the polymeric material to thecannula mandrel assembly to provide a desired material thickness coatingon the cannula mandrel assembly; at least partially curing the coatingof the polymeric material on the cannula mandrel assembly to form thecannula; disassembling the cannula mandrel assembly by first slidingboth the facepiece mandrel and the formed cannula along themouthpiece/nasal mandrels toward the free leading ends of themouthpiece/nasal mandrels until the facepiece mandrel and the partiallycured cannula are completely removed from the pair of mouthpiece/nasalmandrels; and then withdrawing the facepiece mandrel from the formedcannula.

The invention also relates to a nasal and oral cannula having a pair ofnares and a pair of mouthpieces with a contiguous flow path between thepair of nares and the pair of mouthpieces, the nasal and oral cannulamanufactured by the method comprising the steps of: assembling a cannulamandrel assembly comprising separable engageable parts including afacepiece mandrel and a pair of mouthpiece/nasal mandrels, anintermediate section of the facepiece mandrel being provided with a pairof spaced apart conical through holes for each receiving a remote freeend of one of the mouthpiece/nasal mandrels and allowing the facepiecemandrel to slide along the pair of mouthpiece/nasal mandrels, and eachof the mouthpiece/nasal mandrels having a tapering conical section whichforms a stop which prevents further sliding movement of the facepiecemandrel along the pair of mouthpiece/nasal mandrels and while alsoavoiding flow of a polymeric material between the facepiece mandrel andthe mouthpiece/nasal mandrels; heating the cannula mandrel assembly to adesired temperature; providing an uncured polymeric material in flowablestate; applying at least one coating of the polymeric material to thecannula mandrel assembly to provide a desired material thickness coatingon the cannula mandrel assembly; at least partially curing the coatingof the polymeric material on the cannula mandrel assembly to form thecannula; disassembling the cannula mandrel assembly by first slidingboth the facepiece mandrel and the formed cannula along themouthpiece/nasal mandrels toward the free leading ends of themouthpiece/nasal mandrels until the facepiece mandrel and the partiallycured cannula are completely removed from the pair of mouthpiece/nasalmandrels; and then withdrawing the facepiece mandrel from the formedcannula.

The invention further relates to a nasal and oral cannula having firstand second nares and first and second curved mouthpieces with acontiguous flow path between the first and second nares and the firstand second mouthpieces, the nasal and oral cannula comprising: a mainbody having opposed end openings and defining a single internalcompartment; the first nare, for insertion into a nostril of a patient,being coupled to the main body and communicating with the internalcompartment, and the first nare having an inlet/outlet opening at a freeend thereof; the second nare, for insertion into a second nostril of thepatient and spaced from the first nare, being coupled to the main bodyand communicating with the internal compartment, and the second narehaving an inlet/outlet opening at a free end thereof; the first curvedmouthpiece being coupled to the main body and communicating with theinternal compartment, and the first mouthpiece having an inlet/outletopening at a free end thereof; the second curved mouthpiece, spaced fromthe first mouthpiece, being coupled to the main body and communicatingwith the internal compartment, and the second mouthpiece having aninlet/outlet opening at a free end thereof; and the curvature of thefirst and second mouthpieces in combination with an excess length of thefirst and second mouthpieces results in extra length of the mouthpieceand facilitates trimming of an excess portion of free ends of the firstand second mouthpieces so that the openings, of both the first andsecond mouthpieces, can be aligned substantially normal to aninhalation/exhalation path of the patient and thereby increase thesensitivity of the cannula.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described, by way of example, with referenceto the accompanying drawings, in which:

FIG. 1 is an orthogonal view of a cannula mandrel assembly with cannulaforming plastics or polymeric material shown in ghost;

FIG. 2 is an orthogonal view of the cannula mandrel parts prior toassembly;

FIG. 3 is a side elevation of the mouthpiece mandrel of FIGS. 1 and 2showing an end connector;

FIG. 4 is an end section of the end connector taken along section line4-4 of FIG. 3;

FIG. 5 is a fragmentary side elevation of the main body mandrel of FIGS.1 and 2 taken along section line 5-5 of FIG. 2;

FIG. 6 is an elevation of the main body mandrel taken in the directionof arrow 6 in FIG. 5;

FIG. 7 is a diagrammatic cross-sectional view of a cannula, made by themethod of the present invention, taken along section line 7-7 of FIG. 1;

FIG. 8 is a flow diagram of the method of the present invention;

FIG. 9 is an orthogonal view of a cannula mandrel assembly for forming aseptum or barrier in a void of the main body forming mandrel, withcannula forming plastics or polymeric material shown in ghost;

FIG. 10A a front elevational view of another embodiment showing apartially assembled mandrel assembly having the pair of mouthpiecemandrels assembled with the pair of sections of the main body mandrel;

FIG. 10B a front elevational view of only the pair of sections of themain body mandrel;

FIG. 10C a side elevational view of one prong for forming the gas flowpassageway in the mouthpiece;

FIG. 10D a front elevational view of the prong of FIG. 10C;

FIG. 11 is a diagrammatic orthogonal view of a cannula, manufacturedfrom the mandrel assembly of FIG. 10, having a pair of separatemouthpieces and two separate flow passageways;

FIG. 11A is a diagrammatic side elevational view of a cannula of FIG.11;

FIG. 12A is a side elevational views showing the originally moldedorientation of the mouthpiece relative to an open mouth of a patient;

FIG. 12B is a side elevational view showing the trimmed orientation ofthe mouthpiece, relative to an open mouth of a patient, for aligning anopening of the mouthpiece with the patient's oral inhalation/exhalationpath;

FIG. 13 a front elevational view of a further embodiment showing apartially assembled mandrel assembly having the pair of mouthpiecemandrels assembled with the pair of sections of the main body mandrel;

FIG. 13A a front elevational view of only the pair of sections of themain body mandrel;

FIG. 13B is a diagrammatic view of a cannula, manufactured from themandrel assembly of FIG. 13A, having a pair of mouthpieces which arejoined with one another along their entire lengths but still providedtwo separate flow passageways;

FIG. 14 a front elevational view of still another embodiment showing apartially assembled mandrel assembly having the pair of mouthpiecemandrels assembled with the pair of sections of the main body mandrel;

FIG. 14A is a diagrammatic view of a cannula, manufactured from themandrel assembly of FIG. 14, having a pair of mouthpieces which arejoined with one another along a portion of their lengths but stillprovided two separate flow passageways;

FIG. 15 a front view of yet another embodiment showing a partiallyassembled mandrel assembly having the pair of mouthpiece mandrelsassembled with the pair of sections of the main body mandrel;

FIG. 15A is a diagrammatic orthogonal view of a cannula, manufacturedfrom the mandrel assembly of FIG. 15, having a pair of separatemouthpieces and two separate flow passageways;

FIG. 16A is a diagrammatic side elevational view of a combinedmouthpiece/nasal mandrel;

FIG. 16B is a diagrammatic front view of the facepiece mandrel;

FIG. 16C is a diagrammatic top plan view of the facepiece mandrel ofFIG. 16B;

FIG. 16D is a perspective view following assembly of facepiece mandrelswith a pair of combined mouthpiece/nasal mandrels to form two cannulaforming assemblies for each forming a cannula;

FIG. 16E is an enlarged diagrammatic view showing the intimateengagement between the tapering conical surface of the mouthpiece/nasalmandrel and the mating conical hole of the facepiece mandrel;

FIG. 16F is a diagrammatic front elevational view of a cannula,manufactured from the mandrel assembly of FIG. 16D, having a pair ofseparate mouthpieces with two nares and a single internal compartment orchamber;

FIG. 16G is a diagrammatic right side elevational view of a cannula ofFIG. 16F;

FIG. 16H is a diagrammatic rear elevational view of a cannula,manufactured from the mandrel assembly of FIG. 16D, having a pair ofseparate mouthpieces with two nares, a single internal compartment orchamber and a reinforcing wire; and

FIG. 16I is a diagrammatic left side elevational view of a cannula ofFIG. 16G.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Referring to FIG. 1, the main body forming mandrel 1 of a berylliumcopper cannula mandrel assembly 3 is shown with a pair of spaced apartnare forming mandrels 5 and 7, and a separate mouthpiece forming mandrel9 having an end connector 11 for joining the mouthpiece mandrel 9 to themain body forming mandrel 1. A cannula 2′, to be formed on the assembly,is shown in ghost and such cannula generally comprises a main body 1′, apair of nares 5′, 7′ and a mouthpiece 9′ which are typicallymanufactured from polyvinyl chloride (PVC), for example.

FIG. 2 shows the mandrel assembly components prior to assembly in orderto form or produce the cannula mandrel assembly 3. Each of the naremandrels 5 and 7 has a reduced diameter section 13 or 15 which form thenares 5′, 7′, respectively, over which cannula forming plastics orpolymeric material is applied. Reduced diameter sections 13 and 15 ofthe nare mandrels 5 and 7 matingly slide into and are received byrespective blind holes 17 and 19 of main body mandrel 1 (see FIG. 5) forreleasbly retaining the nare mandrels 5 and 7 therein. Main body mandrel1 also has a central rectangular recessed section 21 which slidablymates and receives the end connector 11 of the mouthpiece mandrel 9 forreleasbly retaining the mouthpiece mandrel 9 therewith.

Nare mandrels 5 and 7 also have enlarged diameter sections 23 and 25which facilitate support a plurality of identical cannula mandrelassemblies 3 in a jig (not shown) during the molding process.Additionally, the enlarged diameters enable sections 23 and 25 toprovide a larger contact surface which allows easier gripping of naremandrels 5 and 7 to facilitate removal of the nare mandrels 5 and 7 frommain body mandrel 1 after partial curing of the PVC, or some otherplastisol or plastics, on the cannula mandrel assembly 3.

FIG. 2 further shows the mouthpiece mandrel 9 with the end connector 11which has a centrally located slot 27 (see FIG. 3) which slidablyengages with the rectangular section 21 of the main body mandrel 1. Slot27 is sized to permit close contact or engagement of the slot 27 withthe rectangular section 21 of main body mandrel 1 such that a snug fitor attachment is obtained so as to removably retain the mouthpiecemandrel 9 on the main body mandrel 1 while also facilitating extractionof the mouthpiece mandrel 9 from the rectangular section 21 followingpartial curing of the PVC, or some other plastisol or plastics material,on the cannula mandrel assembly 3. The outer surface of end connector 11is sized to approximate a continuation of the outer surface or diameterof main body mandrel 1 to provide a substantially uniform amount ofapplied PVC, or some other plastisol or plastics material, to anexterior surface of the cannula mandrel assembly 3 while stillfacilitating withdrawal of the mouthpiece mandrel 9 from the cannulamandrel assembly 3 and the mouthpiece 9′ of the manufactured cannula.

FIG. 3 shows the general contour of the mouthpiece mandrel 9 having adesired radius X with the end connector 11 located at one end of themouthpiece mandrel 9 and having a slot 27 formed in the end connector11. An end of the mouthpiece mandrel 9, adjacent the end connector 11,is generally straight and not curved.

FIG. 4 is a view along section line 4-4 of FIG. 3 which shows the shape,e.g., the length, the width, and the thickness, of the end connector 11and the slot 27.

Referring to FIGS. 5 and 6, a pair of spaced apart blind holes 17 and 19are formed in a central region of the main body mandrel 1. Each blindhole 17 and 19 preferably has a flat or planar bottom surface and issized to matingly receive, via a sliding fit, one of the reduceddiameter sections 13 or 15 of the nare mandrels 5 and 7 in order toengage and releasable support and retain one of the nare mandrels 5 and7 in a proper molding orientation during application of the PVC, or someother plastisol or plastics material, to the cannula mandrel assembly 3for formation of the cannula 2′. The rectangular section 21 is made witha shoulder depth T removed to allow the diameter of end connector 11 ofmouthpiece mandrel 9 to mate approximately flush with the diameter Y ofmain body 1.

The rectangular section 21 is shown preferably with a relieving radii Rat opposed ends of the section. The relief radius R may be omitted ifthe main body mandrel 1 is machined or formed in a manner that allowsthis. Thickness Z of rectangular section 21 permits slot 27 of endconnector 11 of mouthpiece mandrel 9 to firmly but slidably mate withrectangular section 21 and adequately maintain the engagement betweenthose two components with one another during dipping or application ofthe plastics material. Width W of rectangular section 21 is sufficientto closely accommodate end connector 11 of mouthpiece mandrel 9, e.g., avery small clearance fit between those two components is provided.

FIGS. 1 and 2 show nare mandrels 5 and 7 with bend sections 12 and 14.These bend sections 12 and 14 sufficiently curve or direct the nares ofthe cannula 2′, following manufacture of the cannula, so that the naresmay be properly aligned and be received within a patient's nasalcavities.

Although beryllium copper is the preferred material for manufacture ofthe cannula mandrel assembly 3, other materials which possessappropriate working temperature ranges, retain dimensional stability forreuse in a manufacturing environment and will easily and readily releasethe cannula 2′ following partial curing of the PVC, or some otherplastisol or plastics material, may be used. Metals including, but notlimited to, steel, aluminum, bronze, brass, and copper alloys may beused, as well as some plastics materials. Beryllium copper is preferreddue to its ability to transfer heat rapidly and reliably release thecured PVC, plastisol or other plastics material formed on the cannulamandrel assembly 3. Rapid heat transfer is desirable for the materialforming the mandrel assembly both during heating of the cannula mandrelassembly 3 and following application of the cannula forming plastics orpolymeric material where a partial cure of the plastics or polymericmaterial is followed by rapid cooling.

Prior to application of a plastics or polymeric solution, such as PVC,the cannula mandrel 3 is coated, usually by dipping step or sprayprocess, with a silicone release layer or agent to facilitate separationand/or removal of the mandrel components from the plastics or polymericmaterial to be applied. The application of the plastics or polymericmaterial, in the preferred embodiment, is by dipping the silicone coatedcannula mandrel assembly 3 which has been heated in an oven at an oventemperature of from about 350° F. to about 550° F. (preferably about450° F.) for about 1 to about 3 minutes prior to dipping in a plastisolsolution of PVC. One or more dipping steps may be performed to achievethe desired finished cannula material thickness and each of thesedipping steps may be for a duration of 10-30 seconds, for example.During dipping, the mandrel is supported by the outer free enlargedsections 23 and 25 of the nare mandrels.

The use of a plastisol solution, such as PVC, provides a semi-clearfinished cannula with sufficient strength to withstand subsequentattachment of various connectors while still being sufficientlyflexibility to prevent injury or irritations to the user. Alternatively,other plastics or polymeric materials, which have material propertiessuitable for this method, capable of forming a plastisol, may besubstituted for PVC.

Partial curing of the cannula takes place on the mandrel assembly 3. Thecannula mandrel assembly, with the partially cured PVC thereon, is thenplaced in an oven, for a sufficient time, for further curing at atemperature from about 410° F. to about 450° F. Following curing tostabilize the PVC and after the cannula has sufficiently cooled, themandrel components are then removed from the manufactured cannula andthe release layer or agent assists with such removal, without damagingthe cannula. The resulting manufactured nasal cannula has sufficientphysical strength and retains its manufactured configuration.

Using the inventive method, a cannula with two nares and a mouthpiece isformed as follows: a cannula mandrel assembly 3 is formed by first,slidably mating and engaging the reduced diameter sections 13 and 15 ofnare mandrels 5 and 7 into the blind holes 17 and 19, respectively, ofthe main body mandrel 1; second, orienting nare mandrels 5 and 7 so thatthey are properly aligned as shown in FIG. 1; third, slidably mating orengaging the slot 27 of the end connector 11 of the mouthpiece mandrel 9with the rectangular section 21 of the main body mandrel 1 in a desiredorientation relative to the nare mandrels 5 and 7 so that it is alsoproperly aligned as shown in FIG. 1; fourth, supporting the mandrelassembly in a jig and providing a silicone release layer or agentsubstantially encompassing the mandrel components; fifth, heating theassembled cannula mandrel assembly in an oven at a temperature of fromabout 350° F. to about 550° F.; sixth, providing a liquid uncuredplastisol solution (PVC); seventh, dipping the cannula mandrel assemblyinto the liquid uncured plastisol solution (PVC), at least once, untilthe desired material thickness is built-up and/or achieved on theexterior surface of the mandrel assembly 3; eighth, at least partiallycuring the plastisol (PVC) at a temperature of about 410° F. to about450° F.; and ninth, following sufficient curing, removing the naremandrels 5 and 7 from the blind holes 17 and 19 of main body mandrel 1and the nares 5′, 7′ by pulling on enlarged diameter sections of thenare mandrels 5 and 7, and removing the mouthpiece mandrel 9 from themouthpiece 9′ by disengaging the slot 27 of the end connector 11 fromthe rectangular section 21 of the main body mandrel 1 and pulling themouthpiece mandrel 9 out through the mouthpiece 9′; and finally slidablyremoving main body mandrel 1 from the main body 1′ of the cannula byextracting or withdrawing the same from one end of the manufacturedcannula 2′.

FIG. 7 shows a diagrammatic cross sectional view of a finished ormanufactured cannula 2′, following removal of the components of thecannula mandrel assembly 3 from the cured PVC cannula, and the formedinternal contiguous flow paths through the main body 1′, the nares 5′and 7′ and the mouthpiece 9′ can be seen.

It will be appreciated that the curing step may be completed in twostages, namely, a first partial cure of the PVC produced by the heatedcannula mandrel assembly 3 which is sufficient to maintain the PVC onthis assembly and a second stage in an oven at the above indicatedcuring temperatures to complete curing, following the partial curing ofthe PVC, of the plastisol or some other plastics material.

It will be further appreciated that the opposed outer ends of the mainbody 1′ of the manufactured cannula 2′ may be trimmed, as necessary ordesired, to provide a discrete area where a flexible connecting tubingor conduit may be connected subsequently thereto, e.g., by solventbonding with MEK (methyl ethyl ketone) for example, and the mouthpiece9′ may be trimmed to a desired length, prior to use, to suit anindividual patient so as to maximize the sensitivity of the finishedcannula, e.g., sensing patient breathing, monitoring end tidal CO₂ in apatient's blood stream or supplying a treating gas to the patient.

It will also be understood that disassembly of the cannula mandrelassembly 3, following curing of the cannula forming polymeric material,can proceed by removing the mouthpiece mandrel before the nare mandrelsas an obvious alternative method step, prior to removal of the main bodymandrel.

One modification of the present invention relates to the addition orformation of an internal wall or septum in the internal passage of thecannula 2′ to provide an internal partition or barrier therein, e.g.,form a “divided cannula.” The septum 29 divides the internal chamber Cof the main body 1′ of the cannula 2′ into two completely separatecompartments or passageways C1 and C2 so that a first one of the nares5′ can be coupled to a treating gas, such an oxygen source (not shown),to facilitate the supply of supplemental oxygen to one of the nostrilsof a patient while the other one of the nares 7′ and the centralmouthpiece 9′ can be coupled to a monitoring device (not shown), such asa transducer, to facilitate monitoring of breathing of the patient orcoupled to a demand oxygen conserving device (not shown) while thepatient, at the same time, is still able to receive a supplementalsupply of oxygen, either continuously or intermittently, during thesensed breathing cycle. Alternatively, one of the nares 5′ can beconnected to a capnograph, for example, to sample the exhaled breath ofa patient and detect the end tidal CO₂ in the blood stream of a patientor sensing of patient breathing.

In order to manufacture the septum 29, the main body forming mandrel 1is formed as first and second separate, slightly spaced apart mandrelcomponents 30, 31 which remain spaced apart from one another, by a smallgap or void 32, following assembly of the cannula mandrel assembly 3 andduring application of the polymeric material or dipping operation of themanufacturing process so that the void 32 between the first and thesecond separate, slightly spaced apart mandrel components 30, 31 becomesfilled with PVC, or some other plastisol or plastics material, and formsthe septum 29. Once the cannula is adequately cured, the septum 29 formsan internal partition or barrier within the main body 1′ of the cannulawhich divides the internal chamber C into two completely separatecompartments or passageways C1 and C2.

Following sufficient curing, the nare mandrels 5 and 7 are removed fromthe blind holes 17 and 19 of main body mandrel 1 and the nares 5′, 7′ bypulling on enlarged diameter sections of nare mandrels 5 and 7, themouthpiece mandrel 9 is removed from the mouthpiece 9′ by disengagingthe slot 27 of the end connector 11 from the rectangular section 21 ofthe main body mandrel 1 and pulling the mouthpiece mandrel 9 out throughthe mouthpiece 9′; and the first and second spaced apart components 30,31 of the main body mandrel 1 are finally removed from the main body 1′of the cannula by pulling the first and second spaced apart components30, 31 axially away from one another and out from the main body 1′ ofthe cannula 2′. As discussed above, the opposed outer ends of the mainbody 1′ of the manufactured cannula 2′ may be trimmed, as necessary ordesired, to facilitate connection of a connecting tubing or conduit toeach opposed end of the manufactured cannula.

This variation of the manufacturing process is suitable for intermittentnocturnal oxygen delivery even though the patient breaths through his orher mouth or alternates breathing through his or her nose and mouth.

As can be seen in FIGS. 10A-10D and 11, another embodiment of thecannula mandrel assembly 3, for forming a divided cannula having a pairof spaced apart mouthpieces, is shown. For the sake of clarity, the naremandrels 5 and 7 are not shown attached respectively to the first or thesecond sections 1A, 1B of the main body forming mandrel 1. The firstmouthpiece mandrel 49 comprises a first prong 53 for forming a first gaspassageway 77 in the first mouthpiece of the manufactured cannula 60 andthe second mouthpiece mandrel 49′ comprises a second prong 53′ forforming a second gas passageway 79 in the second mouthpiece of themanufactured cannula 60. A further description of the same followsbelow.

In order to attach both the first and second mouthpiece mandrels 49, 49′to the main body mandrel 1, each of the first and second mouthpiecemandrels 49, 49′ include an end connector 51 (see FIG. 10C) attached toa connecting end 59 of the respective first and second prongs 53, 53′.The end connector 51 has a centrally located slot 57 which slidablyreceives or engages one of the two rectangular sections 21A, 21B (seeFIG. 10B) formed in one of the two spaced apart but adjacent bodysections 1A, 1B forming the main body mandrel 1, as described above.Each slot 57 is sized to closely contact and engage the respectiverectangular section 21A or 21B of main body mandrel 1 of each bodysection 1A, 1B such that a snug fit and retention of each respectivemouthpiece mandrel 49, 49′ with the main body mandrel 1 is obtained bothprior to and during dipping while still also facilitating removal orextraction of the mouthpiece mandrels 49, 49′ from rectangular sections21A, 21B following sufficient curing and cooling of the PVC, or someother plastisol or plastics material. As with the other embodiments, theouter surface of end connector 51 has a shape, a size and/or a contourwhich approximates the outer diameter of the main body mandrel 1 toprovide a uniform diameter of applied cannula forming polymeric materialwhile also facilitating withdrawal of the mouthpiece mandrels 49, 49′from the mouthpieces 69, 69′ of the manufactured cannula 60 (see FIG.11).

The first and second mouthpiece mandrels 49, 49′, once coupled to themain body mandrel 1, extend parallel to but are spaced apart from oneanother by a small distance, e.g., 1/16 to 1½ inches or so, morepreferably spaced from one another by a distance of about ¼ to about 1inch. The first and second prongs 53, 53′ each have a cross sectionalarea of between about 0.006 and about 0.007 square inches and a radiusof curvature R1 of between about 0.5 of an inch to about 2.5 inches orso, and more preferably a radius of curvature of between about 0.75 ofan inch to about 1.25 inches or so. The radius of curvature R1 can varybut is generally chosen to facilitate the alignment of the cannulamouthpiece with an opening of the mouth of a patient. The separationbetween the first and second prongs 53, 53′, according to thisembodiment, forms a uniform elongate spacing or area between those twoprongs so that a sufficient space is provided during the dippingoperation(s), which applies a plastisol coating to the cannula mandrelassembly 3 and each of the first and second prongs 53, 53′ without anyplastisol interconnecting or joining the two mouthpieces 69, 69′ withone another. As a result of this, the two mouthpieces 69, 69′ arecompletely separate and movable independent of one another followingformation of the cannula 60.

The transverse cross sectional area D (see FIG. 11) of the openings 83,87 and the internal gas flow passageway 77, 79 within the mouthpiece 69,69′ of the cannula, once the first and second prongs 53, 53′ are removedtherefrom, are sufficiently sized for supplying a desired treating gasto a patient, for example, via a demand regulator to a mouth breathingpatient. Alternatively, the respective internal gas flow passagewaywithin the mouthpiece 69, 69′ of the cannula is sufficiently sized toallow withdrawal, detection, sampling, etc., of an exhalation gas(es)from a mouth of a breathing patient. It is to be appreciated that thetransverse cross sectional area of the internal gas flow passageway,formed in the mouthpiece 69, 69′, for supplying a treating gas to apatient may typically be larger than the transverse cross sectional areaof a gas flow passageway for withdrawing or sampling a gas(es) from apatient. If desired, a first and/or second prong 53, 53′ with a largeror smaller transverse cross sectional area, to thereby define acorrespondingly larger or smaller internal gas flow passageway(s) 77and/or 79 in either or both the first and the second mouthpieces 69,69′, could be utilized. But, for the sake of simplicity of manufactureand for added versatility, the transverse cross sectional areas of bothof the formed internal gas flow passageways 77, 79 in the first andsecond mouthpieces 69, 69′ can be manufactured identical to one another.

The above described first and second mouthpiece mandrels 49, 49′ areeach assembled with one of the body sections 1A or 1B of the main bodymandrel 1 and one of the first and second nare mandrels 5, 7 to form thecannula mandrel assembly 3. Before dipping or application of thepolymeric material, the cannula mandrel assembly 3 is sprayed orotherwise coated with a release film, layer or agent and pre-heated to adesired temperature and then dipped in or otherwise applied with thecannula forming polymeric plastisol to provide a desired thickness orlayer of a partially cured plastics or polymeric material on theexterior surface of the cannula mandrel assembly 3 and thereby form amanufactured plastisol cannula. The partially cured manufacturedplastisol cannula is then heated in an oven to further cure the plasticsor polymeric material, as previously described. After sufficient curingof the plastics or polymeric material, both of the first and second nareforming mandrels 5, 7, the first and second mouthpiece forming mandrels49, 49′ and the first and second sections 1A, 1B of the main bodyforming mandrels 1 are extracted or removed from the cured polymericmaterial and the remaining cured structure results in the manufacturedand cured cannula 60, as shown in FIG. 11. If desired or necessary, theend of the cannula 60 can be trimmed to a desired length.

The manufactured cannula 60, formed from the above described process andcannula mandrel assembly 3 shown in FIGS. 10A-10D, after addition of thenare mandrels 5 and 7, comprises a main body 71 with a pair of opposedinternal chamber end openings 73, 75 located at opposite ends of themain body 71 for coupling, by an adhesive such as MEK for example, eachopposed end of the cannula 60 to a flexible gas delivery, pressuredetecting or gas sampling tubing or some other conduit 74, 76 (onlypartially shown in FIG. 11). The gap or spacing formed between theadjacent ends of the first and second sections 1A, 1B of the main bodyforming mandrel 1 (see FIGS. 10A and 10B) creates a partition, a wall, adividing member or a septum 81 which divides the internal chamber C intoa first compartment or passageway C1 and a completely separate secondcompartment or passageway C2. The first compartment or passageway C1communicates with the first chamber end opening 73 while the secondseparate compartment or passageway C2 communicates with the secondchamber end opening 75. A first fluid passageway 91, formed in the firstcentrally located nare 65, communicates with the first compartment orpassageway C1 while a second fluid passageway 95, formed in a secondcentrally located nare 67, communicates with the second separatecompartment or passageway C2. The first gas passageway 77, formed in thefirst mouthpiece 69, communicates with the first compartment orpassageway C1 while the second gas flow passageway 79, formed in thesecond mouthpiece 69′, communicates with the second separate compartmentor passageway C2. The pair of centrally located but spaced apart nares65, 67 of the cannula are located for insertion into the nostrils of apatient's nose while the first and second centrally located mouthpieces69, 69′ of the cannula are located substantially adjacent the middlesection of the main body 71, between the nares 65, 67, for communicationwith the mouth of the patient.

As best seen in FIG. 11A, the first and second mouthpieces 69, 69′ ofthe nasal cannula 60 are shown in their originally molded shape orconfiguration which generally corresponds to the curvature of themouthpiece mandrel 49. As can be appreciated, due to the nature of theresiliency of the plastisol material from which the cannula 60 isformed, the first and second mouthpieces 69, 69′ will generally retainand/or return back to such originally molded curvature. As discussedabove, the mouthpiece 69, 69′ may be trimmed to a desired length (shownin dashed lines in FIG. 12B) to suited an individual patient so as tomaximize the sensitivity of the cannula, e.g., sensing patientbreathing, monitoring end tidal CO₂ in a patient's blood stream,supplying a treating gas to the patient, detecting sleep apnea, etc.That is, the gas passage openings 83 and 87 are generally aligned with,e.g., extends substantially perpendicular to, the exhalation/inhalationpath E of the patient.

It is to be appreciated that the nasal cannula 60 is a unitary structurewhich comprises two completely separate internal flow paths 96 and 98.Each one of the two completely separate internal flow paths 96 and 98 issuitable for supplying a treating gas to a patient both via a nostriland the mouth of a patient as well as capable of withdrawing or samplingan exhalation gas(es) from the patient, or monitoring breathingcharacteristics, detecting pressure, etc. The first compartment orpassageway C1, of the internal chamber C of the main body of the cannula60, is in constant and continuous communication with the first gaspassageway 77 of the first mouthpiece 69 and also in constant andcontinuous communication with the first gas passageway 91 in the firstnare 65 and with the first chamber end opening 73 and all of thesecomponents and passageways form the first completely separate internalflow path 96. The second compartment or passageway C2, of the internalchamber C of the main body of the cannula 60, is in constant andcontinuous communication with the second gas passageway 79 of the secondmouthpiece 69′ and also in constant and continuous communication withthe second gas passageway 95 in the second nare 67 and with the secondchamber end opening 75 and all of these components and passageways formthe second completely separate internal flow path 98. As a result ofthese completely separate fluid passageways 96, 98, each completelyseparate fluid passageway 96 or 98 can facilitate preforming one of thefollowing functions: monitor breathing of a patient via the mouth and/orthe nose, sampling the end tidal CO₂ content in the exhaled breath of apatient via the mouth and/or the nose to determine the patient's CO₂concentration level in the blood, supplying a treating gas to a patientvia the mouth and/or the nose, detecting apnea via the mouth and/or thenose, etc. If desired, the septum 81 may be eliminated so that the firstand second compartments or passageways C1 and C2, the first and secondinternal gas passageways 77, 79 and the first and second gas passageways91 and 95 in the nares 65 and 67 are all in constant and continuouscommunication with one another.

It is to be appreciated that it is not necessary to have the twomouthpieces 69, 69′ precisely centered between the nares 65, 67. It isconceivable that the mouthpieces could be located on one side or theother of a central plane P bisecting a center of main body 71 into twohalves. It is to be appreciated further that it is not necessary to havethe septum 81 center within the main body as long as the septum 81 isgenerally located between the nares 65, 67 and the first and secondmouthpieces 69, 69′. Also, as set forth in U.S. Pat. No. 6,439,234 toCurti et al., the disclosure of which is hereby incorporated byreference, additional openings 100 (shown as dashed lines in FIG. 11),preferably adjacent the remote free end of each nare, could be providedin the nares 65, 67 and possibly in the gas passageway 69, 69′ of themouthpiece to prevent occlusion of the nares 65, 67 and facilitatemonitoring, detecting, sampling, delivery, etc.

As can be seen in FIG. 11A for example, the first end of the nares 65and 67 generally form an angle of between about 180° or so ±5 degreeswith the coupled end of the mouthpieces 69, 69′.

FIG. 12A shows a typical orientation of the mouthpieces 69, 69′,relative to an open position of a patient's mouth following initialinstallation of the cannula on the patient. As can be readily observedin FIG. 12A, it is possible that the gas passage openings 83 and 87 maynot initially be precisely aligned with the exhalation/inhalation path Eof the patient, e.g., the plane defined by the gas passage openings 83and 87 may not extend substantially normal to the exhalation/inhalationpath E of the patient as her or she breaths normally. The remote freeend of the mouthpieces 69, 69′ can be cut or trimmed, as necessary (seeFIG. 12B in which the removed or trimmed portion of the mouthpieces 69,69′ is shown in dashed lines), so that thereafter a plane defined by theopenings to the internal gas passageways 77, 79 of the mouthpieces 69,69′ will lie substantially normal to the exhalation/inhalation path E ofthe patient. Such alignment of the openings 83 and 87 to the internalgas passageways 77, 79 of the mouthpieces 69, 69′ assists with bettercollection of a gas sample(s), more accurate detection of an exhalationpressure, more accurate delivery of a gas(es), more accurate monitoringof the patient's breathing, etc. The above described arrangement permitsminor adjustment of the configuration and/or orientation of themouthpieces 69, 69′ prior to use.

With reference to FIGS. 13 and 13A, another embodiment of the cannulamandrel assembly will now be discussed. For the sake of clarity, thenare mandrels are not shown attached respectively to the first or thesecond sections 1A, 1B of the main body forming mandrel 1 in FIG. 13. Asthis embodiment is similar to the previous embodiments, identicalreference numerals are given to identical elements and only thedifferences between this embodiment and the embodiment of FIGS. 10A-10D,in particular, will be discussed in detail.

The principal difference between this embodiment and the embodiment ofFIGS. 10A-10D is that the rectangular sections 21A and 21B are locatedslightly closer to one another so the first and second prongs 53, 53′,when engaged therewith, are mounted in a closer relationship to oneanother. That is, each rectangular section 21A and 21B is located about0.0290 inches of so from an end of either the first or the secondsections 1A, 1B of the main body forming mandrel 1 and so that adjacentedges of the first or the second sections 1A, 1B are spaced from oneanother by a distance of about 0.050 inches. This results in the firstand second prongs 53, 53′, when engaged with the respective rectangularsections 21A, 21B, being spaced or separated from one another by only adistance of about 0.1100 inches or so.

The net result of this modification occurs during the dipping process orapplication of the polymeric material. That is, during the dippingprocess or application of the polymeric material, the first and secondprongs 53, 53′ are located sufficiently closed to one another such thatthe plastisol at least partially fills the space or gap located betweenthe first and second prongs 53, 53′ and forms an interconnecting web 89and well as encases and surrounds each one of the first and secondprongs 53, 53′ to form an integral mouthpiece comprising a pair ofjoined or interconnected mouthpieces 69, 69′ (see FIG. 13A) which movein unison with one another. In all other respects, this embodiment issubstantially identical to the embodiment of FIGS. 10A-10D, 11 and 11A.

With reference to FIGS. 14 and 14A, another embodiment of the cannulamandrel assembly will now be discussed. For the sake of clarity, thenare mandrels are not shown attached respectively to the first or thesecond sections 1A, 1B of the main body forming mandrel 1 in FIG. 14. Asthis embodiment is similar to the previous embodiments, identicalreference numerals are given to identical elements and only thedifferences between this embodiment and the embodiment of FIGS. 10A-10D,in particular, will be discussed in detail.

The principal difference between this embodiment and the embodiment ofFIGS. 10A-10D is that each one of the first and second prongs 53, 53′has a small inwardly directed bend or transition 85 formed adjacent theconnecting end 59 of the respective first and second prongs 53, 53′. Asa result of this small inwardly directed bend or transition 85 towardone another, when the first and second prongs 53, 53′ are engaged withthe respective first and second sections 1A, 1B, the connecting ends 59are located further away from one another while the remote free ends ofthe first and second prongs 53, 53′ are located in a closer spacedrelationship to one another. That is, the connecting ends 59 of thefirst and second prongs 53, 53′ are spaced from one another by adistance of about 1/16 to ½ inch while the remote free ends of the firstand second prongs 53, 53′ are spaced from one another by a distance ofabout 0.110 inches or so, similar to the embodiment of FIGS. 13 and 13A.

The net result of this modification occurs during the dipping process orapplication of the polymeric material. That is, during the dippingprocess or application of the polymeric material, the remote free endsof the first and second prongs 53, 53′ are located sufficiently closedto one another such that the plastisol at least partially fills thespace or gap between the first and second prongs 53, 53′ to form a web89 therebetween, as well as encases and surrounds each one of the firstand second prongs 53, 53′ to thereby result in an integral mouthpiececomprising a pair of joined or interconnected mouthpieces 69, 69′, oncethe first and second prongs 53, 53′ are removed, which move in unisonwith one another. In all other respects, this embodiment issubstantially identical to the embodiment of FIGS. 10A-10D, 11 and 11A.A through hole 93, which does not contain any plastisol, is formed inthe cannula 60 and spaces the web 89 from the main body 71.

With reference to FIGS. 15 and 15A, a still further embodiment of thecannula mandrel assembly will now be discussed. For the sake of clarity,the nare mandrels are not shown attached respectively to the first orthe second sections 1A, 1B of the main body forming mandrel 1 as seen inFIG. 15. As this embodiment is similar to the previous embodiments,identical reference numerals are given to identical elements and onlythe differences between this embodiment and the embodiment of FIGS.10A-10D, in particular, will be discussed in detail.

The principal difference between this embodiment and the embodiment ofFIGS. 10A-10D is that each one of the first and second prongs 53, 53′has a very gradual inclination or taper 85′ toward one another,commencing adjacent the connecting end 59 of the respective first andsecond prongs 53, 53′ and extending all the way to the free ends of thefirst and second prongs 53, 53′. As a result of very gradual inclinationor taper toward one another, when the first and second prongs 53, 53′are engaged with the respective first and second sections 1A, 1B, theremote free ends of the first and second prongs 53, 53′ are located invery close or possibly in abutting engagement or contact with oneanother. That is, the remote free ends of the first and second prongs53, 53′ are either in contact with one another or spaced from oneanother by a distance of less than 0.050 inches or so.

The net result of this modification occurs during the dipping process orapplication of the polymeric material. That is, during the dippingprocess or application of the polymeric material, the remote free endsof the first and second prongs 53, 53′ are located sufficiently closedto one another such that the plastisol at least partially fills thespace or gap between the first and second prongs 53, 53′ to form a web89 therebetween, as well as encases and surrounds each one of the firstand second prongs 53, 53′ to thereby result in an integral mouthpiececomprising a pair of joined or interconnected mouthpieces 69, 69′ which,once the first and second prongs 53, 53′ are removed, move in unisonwith one another. The opening for the two passageways 77, 79 is, inessence, a single common enlarged opening communicating with bothpassageways 77, 79. A through hole 93, which does not contain anyplastisol, is formed in the cannula 60 and spaces the web 89 from themain body 71. In all other respect, this embodiment is substantiallyidentical to the embodiment of FIGS. 10A-10D, 11 and 11A.

According to this application, the term “nasal cannula facepiece”generally comprises: (1) a hollow main body defining an internal chambertherein and having opposed first and second ends; and (2) at least oneand preferably first and second nares which each communicate with theinternal chamber of the main body and define respective first and secondnare passages.

It is to be appreciated that the mouthpiece could also be injectionmolded as a single unitary piece or injection molded as two separatepieces, i.e., the facepiece separately molded from the mouthpiece, whichare subsequently assembled with one another during a furthermanufacturing step. Alternatively, the cannula facepiece could also beeither injection molded or formed by polymeric material which is cured.The cannula mouthpiece could be formed by injection molding, by apolymeric material which is cured, or extruded as a separate piece. Thefacepiece and the mouthpiece are subsequently assembled with one anotherto form a manufactured cannula.

The cannula, manufactured according to the present invention, is primarya divided cannula having two completely separate gas flow paths witheach completely separate flow path communicating both with the nasalcavity, via one of the patient's nostrils, and the mouth or the oralcavity of the patient. Each one of the mouthpieces, for communicatingwith the mouth or the oral cavity of the patient, is molded with asufficient curvature and of a sufficient length such that the free endof both mouthpieces will be typically located closely adjacent, or indirect contact with, the upper lip or lip region of the patient,depending upon the facial contour(s) of the patient. The curvatures ofthe mouthpieces in combination with the excess length of the mouthpiecesresults in extra length of the mouthpiece and facilitates trimming of anexcess portion of the free of the mouthpiece so that the openings, forboth mouthpieces, can be aligned substantially normal to theinhalation/exhalation path of the patient and thereby increase thesensitivity of the cannula.

Although the mouthpiece mandrel(s) is generally described as beingattached to the main body mandrel by a centrally located slot whichslidably engages or receives a rectangular section of the main bodymandrel, it is to be appreciated that other types of releasableconnections between those components could also be utilized, e.g., a pinreceived within a blind hole or blind recess, etc. The important aspectis that the mouthpiece mandrel(s) be adequately retained by the mainbody mandrel, during application of the polymeric material, while stillbeing readily releasable from the main body mandrel, following curing ofthe cannula. The mouthpiece mandrel should also extends radially fromand substantially perpendicular to the main body mandrel.

With reference to FIGS. 16A-16I, another embodiment of the cannulamandrel assembly will now be discussed. As this embodiment is somewhatsimilar to the first embodiment, identical reference numerals are givento identical elements and only the differences between this embodimentand the embodiment of FIGS. 1-8, in particular, will be discussed indetail.

As shown in FIG. 16D, this embodiment includes the cannula mandrelassembly 3″ which has a pair of spaced apart mouthpiece/nasal mandrels101 but this embodiment includes a continuous uninterrupted facepiecemandrel 1″ (see FIGS. 16B and 16C), except for a pair of through holes,so that the manufactured cannula 60″ is undivided (see FIGS. 16F and16G). That is, the manufactured nasal cannula 60″ has a single interiorchamber or compartment C1 and that interior chamber or compartment C1 isin constant and continuous fluid communication with the formedpassageways in the first and second nares and also with formedpassageways in both of the first and the second mouthpieces 69, 69′.

The cannula mandrel assembly 3″ is typically assembled on a molding baseor platform 102, as can be seen in FIG. 16D. A first end of each of apair of substantially identical mouthpiece/nasal mandrels 101 isinserted into a respective pair of spaced apart recess 104 formed in themolding base or platform 102. Each one of the mouthpiece/nasal mandrels101 comprises a straight thickened base section 106 which extendssubstantially perpendicular to the molding base or platform 102. Thethickened base section 106 transitions into a straight thinner basesection 108 and the thickened and thinner base sections 106, 108together have a combined length of at least an inch or so and preferablyhave a combined a length of about 1½ to about 2¼ inches or so. Thethinner base section 108 then transitions into a curved section 110generally having a radius of curvature R1 of between about 0.25 of aninch to about 1.5 inches or so, and more preferably a radius ofcurvature of between about 0.5 of an inch to about 0.75 inches or so.The radius of curvature R1 of the curved section 110 can vary, dependingupon the cannula being manufactured, but is generally chosen tofacilitate the alignment of an opening formed in the free end of themanufactured cannula mouthpiece with the opening of a mouth of thepatient. The curved section 110 of the mouthpiece/nasal mandrels 101forms the mouthpieces of the manufactured cannula 60″. As can be seen inFIG. 16A, the free end 112 of each of mouthpiece/nasal mandrels 101 hasa generally flat end wall 114. The end wall 114 of each of thenasal/mouthpiece/nasal mandrels 101 may be chamfered or otherwisecontoured, e.g., tapered, rounded, pointed, etc., to facilitatereceiving and engagement with a hole formed in the facepiece mandrel 1″and such engagement will be discussed below in further detail.

An intermediate section of the facepiece mandrel 1″ is provided with apair of spaced apart through holes 116 which are suitably spaced apartfrom one another and each is sized to receive a free leading end 112 ofone of the mouthpiece/nasal mandrels 101 and facilitate matingengagement with the facepiece mandrel 1″. The pair of holes 116,provided in the facepiece mandrel 1″, must be sufficiently larger thanthe transverse cross sectional area or dimension of the mouthpiece/nasalmandrels 101 to allow each hole 116 of the facepiece mandrel 1″ toreceive a respective free leading end 112 of one of the mouthpiece/nasalmandrels 101 and also allow the facepiece mandrel 1″ to slide along thecurved section 110 and the thinner base section 108 of both of themouthpiece/nasal mandrels 101 until the facepiece mandrel 1″ abutsagainst a stop feature or element 118 provided in the thinner basesection 108 adjacent the transition between the thinner base section 108and the curved section 110 (see FIGS. 16A and 16D). The stop feature orelement 118 is an interference expansion which prevents further slidingmovement of the facepiece mandrel 1″ along the respective themouthpiece/nasal mandrels 101 toward the molding base or platform 102.It is desirable for the free ends 112 of the mouthpiece/nasal mandrels101 to be spaced apart from one another by a distance slightly largerthan the spacing of the pair of through holes 116 in the facepiecemandrel 1″. That is, the spaced apart recess 104, formed in the moldingbase or platform 102, can be spaced slightly further apart than the holeto hole spacing in the facepiece mandrel 1″ or mouthpiece/nasal mandrels101 can bow or flare slightly away for one another adjacent therespective free leading ends 112. Such spacing results in a slidingfriction between the inner surface of the holes 116 in the facepiecemandrel 1″ and the exterior surface of the mouthpiece/nasal mandrels 101and further assists with retaining the facepiece mandrel 1″ in itsfinally installed position, i.e., engaged with the stop feature orelement 118. The friction, between the facepiece mandrel 1″ and themouthpiece/nasal mandrels 101, ensures that the facepiece mandrel 1″does not become inadvertently disengaged from the stop feature orelement 118 during manufacture or molding of the cannula, especiallyduring the dipping process.

According to this embodiment, the stop feature or element 118 is athickened region area or region in the thinner base section 108 butadjacent the transition between the thinner base section 108 and thecurved section 110. Preferably, this thickened area or region isconically shaped and the two holes 116, provided in the facepiecemandrel 1″, have a mating conically shaped hole 116 which facilitates anintimate mating engagement between the these conically shaped surfacesso as to provide an intimate locking engagement therebetween andfacilitate retaining the facepiece mandrel 1″ in engagement with thestop feature or element 118 of the mouthpiece/nasal mandrels 101 evenwhen the cannula mandrel assembly 3″ is flipped over or otherwisemanipulated during manufacture of the cannula.

Both the thinner base section 108 and the curved section 110 have asubstantially constant transverse cross sectional diameter or dimensionof about 0.062 inches along their length. The holes 116 of the facepiecemandrel 1″ each have a transverse cross sectional diameter or dimensionwhich is slightly larger than the transverse cross sectional diameter ordimension of the mouthpiece/nasal mandrels 101, e.g., larger than thetransverse cross sectional dimension or diameter of the thinner base andcurved sections 108, 110 by between about 0.070 inches or so. The largerdiameter or dimension of the holes 116 facilitate sliding movement ofthe facepiece mandrel 1″, along the exterior surface of themouthpiece/nasal mandrels 101, and also allow the facepiece mandrel 1″to slide relatively freely around the curved section 110 of themouthpiece/nasal mandrels 101. It is to be appreciated that the space orgap, formed between the inwardly facing surface of the holes 116 of thefacepiece mandrel 1″ and the exterior surface of the mouthpiece/nasalmandrels 101 once the facepiece mandrel 1″ abuts against the stopfeatures or elements 118, must be sufficiently small so as to avoid asignificant amount of the plastisol or plastics material from “flashing”or flowing in any space or gap between the facepiece andmouthpiece/nasal mandrels. It is to be appreciated that the transversecross sectional diameter or dimension of the mouthpiece/nasal mandrels101 can vary, i.e., can be other than circular, depending upon theparticular application.

As shown in the drawings, the stop feature or element 118 is a taperingconical section (see FIG. 16E) which is formed integrally with thethinner base section 108 at a location adjacent the transition of thethinner base section 108 into the curved section 110. The taperingconical section 120 has a smaller dimensioned end 122, located remotefrom the molding base or platform 102, with a diameter of about 0.070inches or so while the larger dimensioned end 124 of the taperingconical section, located closest to the molding base or platform 102,has a diameter of about 0.078 inches or so. The mating tapers, betweenthe holes 116 of the facepiece mandrel 1″ and the tapering conicalsection 120 of the thinner base section 108 of the mouthpiece/nasalmandrels 101, provide an intimate contact between the mating conicalsurfaces of these two components which avoids or minimizes formation ofany gaps or spaces therebetween and thus minimizes any “flashing” or theflow of the plastisol or plastics material between the main andmouthpiece/nasal mandrels 101 during manufacture of the cannula.

It is to be appreciated that although the stop feature or element 118 isdescribed as a tapering conical section 120 and a mating conical hole116 in the facepiece mandrel 1″, other complimentary matingarrangements, which both facilitate retaining the facepiece mandrel 1″in position while also minimizing the flow of the plastisol or plasticsmaterial between the facepiece mandrel 1″ and the mouthpiece/nasalmandrels 101 during manufacture of the cannula, would be readilyapparent to those skilled in the art and are considered to be within thespirit and scope of this invention.

Due to the fact that the mouthpiece/nasal mandrels 101 is a singlemandrel, this results in the first nare 65 being aligned and coincidentwith the associated first mouthpiece 69 and the second nare 67 beingaligned and coincident with the associated second mouthpiece 69′.

Following molding of the cannula, according to the process describedabove, the facepiece mandrel 1″, along with the manufactured cannula60″, is disengaged from its intimate locking engagement with the pair ofstop feature or elements 118 of mouthpiece/nasal mandrels 101 by slidingthese components along both of the mouthpiece/nasal mandrels 101 towardthe free ends 112 until both the facepiece mandrel 1″ and themanufactured cannula 60″ disengaged from the free ends 112 and arecompletely removed from both of the mouthpiece/nasal mandrels 101. Next,the facepiece mandrel 1″ is then extracted or removed from themanufactured cannula 60″ by pulling one end of the facepiece mandrel 1″away from the manufactured cannula 60″, via one of the opposed endopenings 73 or 75, until the facepiece mandrel 1″ is completelyseparated and removed from the manufactured cannula 60″ thereby formingthe manufactured cannula 60″.

With reference to FIGS. 16F and 16G, the cannula 60″, manufactured bythe cannula mandrel assembly 3″ of this embodiment, will now bediscussed. The manufactured cannula 60″, formed from the above describedprocess and cannula mandrel assembly 3″ shown in FIG. 16D, comprises amain body 71 with a single internal chamber having end opposed openings73, 75 which are coupled by an adhesive, such as MEK for example, to oneend of a flexible gas delivery, pressure detecting or gas samplingtubing or conduit 74, 76. The opposite end of the sampling tubing orconduit 74, 76 is typically connected to a conventional connector (onlydiagrammatically shown) which facilitates connection to a desireddevice, such as a gas delivery device, a pressure detecting device, agas sampling device, etc. The internal compartment C1 communicates withthe first end opening 73, a first fluid passageway 91 formed in thefirst nare 65 and with a first fluid passageway 77 formed in the firstmouthpiece 69, while the internal compartment C1 also communicates withthe second end opening 75, a second fluid passageway 95 formed in thesecond nare 67 and with a second fluid passageway 79 formed in thesecond mouthpiece 69′. The first fluid passageway 91 communicates with aprimary aperture (inlet/outlet) 97 formed in end surface of the firstnare 65 while the second fluid passageway 95 communicates with a primaryaperture (inlet/outlet) 99 formed in end surface of the second nare 67.The first fluid passageway 77 communicates with an inlet/outlet aperture83 formed in end surface of the first mouthpiece 69 while the secondfluid passageway 79 communicates with an inlet/outlet aperture 87 formedin end surface of the first mouthpiece 69′. The pair of centrallylocated but spaced apart nares 65, 67 are located on the cannula 60″ forinsertion into the nostrils of a patient's nose while the first andsecond centrally located mouthpieces 69, 69′ are both located adjacentthe middle section of the main body 71 for insertion or communicationwith the mouth of the patient.

With reference to FIG. 16H, if desired, the cannula 60 of FIG. 16F canbe provided with a wire 128 to facilitate alignment and retention of themouthpieces in aligned positions during use of the cannula. To achievethis, a first end of the wire 128 is glued or otherwise permanentlyaffixed to an intermediate region of a top surface of the firstmouthpiece 69 and the wire 128 then extends along the mouthpiece towardthe main body 71 of the cannula 60″. The wire 128 bends 90 degrees andthen extends along a top surface of the main body 71 toward the secondmouthpiece 69′ and then again bends 90 degrees and, thereafter, extendsalong the top surface of the second mouthpiece 69′ and terminates in asecond end at an intermediate location along the second mouthpiece 69′.Preferably the wire 128 is glued or otherwise permanently secured to thecannula along its entire length so that the wire 128 does not becomeseparated or dislodged from the cannula 60″. The wire 128 typically hasa diameter of between 0.01 and 0.2 inches or so.

Following manufacture of the cannula 60″, at least one and possibly bothof the spaced apart first and second nares 65, 67 is provided with asecondary aperture 100, along an intermediate length of the nare, toprovide a secondary inlet/outlet of the nare 65, 67 depending upon thefunction of the cannula 60″, which facilitates, via the secondaryinlet/outlet, delivery of a supply gas to the respective nare,monitoring or sampling of a gas from the associated nostril of apatient, etc., in the event that the primary aperture (inlet/outlet) 97or 99 of the respective nares 65, 67 becomes obstructed, clogged oroccluded for some reason, e.g., mucosal secretions and/or soft nasaltissue is sucked into the primary aperture 97 and/or 99 and thus becomespartially or completely blocked, covered or obstructed thereby, etc. Thesecondary apertures 100 to be formed in the nare 65 and/or 67 are sizedto be smaller than the primary aperture (inlet/outlet) 97 and 99 formedin the end of each nare 65, 67 but sufficiently large to function, e.g.,supplying a treating gas to a patient, withdraw or sample an exhalationgas(es) from the patient, monitor breathing characteristics, detectpressure, etc. That is, the secondary aperture (inlet/outlet) 100 of thenare 65, 67 allows the nare to still function in the event that theprimary aperture (inlet/outlet) 97 or 99 becomes obstructed, clogged oroccluded for some reason during use of the cannula so that the nare maystill function. The secondary aperture 100 preferably has a diameter ofbetween 0.05 and 0.07 inches. For ease of manufacture, the secondaryaperture 100 extends through both opposed side walls of the nare 65, 67to form two opposed and identical secondary apertures 100 in the nares65, 67, but two secondary apertures 100 is not required.

Since certain changes may be made in the above described improvedcannula and method of manufacturing the same, without departing from thespirit and scope of the invention herein involved, it is intended thatall of the subject matter of the above description or shown in theaccompanying drawings shall be interpreted merely as examplesillustrating the inventive concept herein and shall not be construed aslimiting the invention.

1. A method of forming a cannula comprising the steps of: assembling a cannula mandrel assembly, which comprises separable engageable parts including a facepiece mandrel and a pair of mouthpiece/nasal mandrels with an intermediate section of the facepiece mandrel being provided with a pair of spaced apart through holes for each receiving a remote free end of one of the mouthpiece/nasal mandrels, by passing the remote free ends of each one of the pair of mouthpiece/nasal mandrels completely through a respective through hole in the facepiece mandrel such that the facepiece mandrel slides along the pair of mouthpiece/nasal mandrels until the through bores of the facepiece mandrel each have an interference fit with a respective larger transverse cross section of the mouthpiece/nasal mandrels which prevents further sliding movement while also avoiding flow of a polymeric material, between the facepiece mandrel and the mouthpiece/nasal mandrels, when applying at least one coating of uncured polymeric material to the cannula mandrel assembly; heating the cannula mandrel assembly to a desired temperature; providing an uncured polymeric material in flowable state; applying at least one coating of the uncured polymeric material to the cannula mandrel assembly to provide a desired material thickness coating on the cannula mandrel assembly; at least partially curing the coating of the polymeric material on the cannula mandrel assembly to form the cannula; disassembling the cannula mandrel assembly by first sliding both the facepiece mandrel and the formed cannula along the mouthpiece/nasal mandrels toward the remote free ends of the mouthpiece/nasal mandrels until the facepiece mandrel and the partially cured cannula are completely removed from the pair of mouthpiece/nasal mandrels; and then withdrawing the facepiece mandrel from the formed cannula.
 2. The method according to claim 1, further comprising the steps of forming the stop feature as a thickened area on each of the mouthpiece/nasal mandrels, and providing the through holes of the facepiece mandrel with a mating complimentary feature which intimately engages with the thickened area of the mouthpiece/nasal mandrels to retain the facepiece mandrel in engagement with the stop feature during manufacture of the cannula and avoid flow of the polymeric material between the facepiece mandrel and the mouthpiece/nasal mandrels.
 3. A method of forming a cannula comprising the steps: assembling a cannula mandrel assembly comprising separable engageable parts including a facepiece mandrel and a pair of mouthpiece/nasal mandrels, an intermediate section of the facepiece mandrel being provided with a pair of spaced apart through holes for each receiving a remote free end of one of the mouthpiece/nasal mandrels and allow the facepiece mandrel to slide along the pair of mouthpiece/nasal mandrels, and each of the mouthpiece/nasal mandrels having a larger transverse cross section stop feature which prevents further sliding movement of the facepiece mandrel along the pair of mouthpiece/nasal mandrels and also avoids flow of a polymeric material between the facepiece mandrel and the mouthpiece/nasal mandrels; forming the stop feature as a thickened area on each of the mouthpiece/nasal mandrels, and providing the through holes of the facepiece mandrel with a mating complimentary feature which intimately engages with the thickened area of the mouthpiece/nasal mandrels to retain the facepiece mandrel in engagement with the stop feature during manufacture of the cannula and avoid flow of the polymeric material between the facepiece mandrel and the mouthpiece/nasal mandrels; and using a tapering conical section as the thickened area on each of the mouthpiece/nasal mandrels, and providing tapering conical holes in the facepiece mandrel as the mating complimentary feature which intimately engage with one another to retain the facepiece mandrel in engagement with the stop feature during manufacture of the cannula; heating the cannula mandrel assembly to a desired temperature; providing an uncured polymeric material in flowable state; applying at least one coating of the uncured polymeric material to the cannula mandrel assembly to provide a desired material thickness coating on the cannula mandrel assembly; at least partially curing the coating of the polymeric material on the cannula mandrel assembly to form the cannula; disassembling the cannula mandrel assembly by first sliding both the facepiece mandrel and the formed cannula along the mouthpiece/nasal mandrels toward the remote free ends of the mouthpiece/nasal mandrels until the facepiece mandrel and the partially cured cannula are completely removed from the pair of mouthpiece/nasal mandrels; withdrawing the facepiece mandrel from the formed cannula.
 4. The method according to claim 2, further comprising the step of inserting a first end of each of the pair of mouthpiece/nasal mandrels into a respective spaced apart recesses formed in a molding base such that the pair of mouthpiece/nasal mandrels are retained and supported by and extend Substantially perpendicular to the molding base.
 5. The method according to claim polymeric material 3, further comprising the steps of forming the tapering conical section of each mouthpiece/nasal mandrels with a smaller dimensioned end, located remote from the molding base, with a diameter of about 0.070 inches while a larger dimensioned end of the tapering conical section, located closest to the molding base, has a diameter of about 0.078 inches.
 6. The method according to claim 3, further comprising the step of forming each one of the mouthpiece/nasal mandrels as a straight base section which transitions into a curved section.
 7. The method according to claim 6, further comprising the step of providing the curved section of each mouthpiece/nasal mandrel with a radius of curvature of between about 0.25 of an inch to about 1.5 inches.
 8. The method according to claim 1, further comprising the step of contouring the remote free end of each of the mouthpiece/nasal mandrels to facilitate receiving and engagement with the holes of the facepiece mandrel.
 9. The method according to claim 1, further comprising the step of manufacturing the cannula mandrel assembly from beryllium copper.
 10. The method according to claim 1, further comprising the step of coating the cannula mandrel assembly with a layer of release material prior to applying the at least one coating of the polymeric material thereto.
 11. The method according to claim 1, further comprising the steps of heating the cannula mandrel assembly at a temperature of from about 350° F. to about 550° F. prior applying the polymeric material to the cannula mandrel assembly; and forming at least one secondary aperture in a sidewall of at least one of the nares.
 12. The method according to claim 1, further comprising the step of applying the polymeric material to the cannula mandrel assembly by at least one dipping step during a dipping process.
 13. The method according to claim 1, further comprising the step of curing the polymeric material by heating the polymeric material at a temperature of from about 410° F. to about 450° F.
 14. The method according to claim 1, further comprising the step of partially curing the polymeric material using heat from the heated cannula mandrel assembly and further curing of the polymeric material in an oven.
 15. The method according to claim 1, further comprising the step of spacing the remote free ends of the mouthpiece/nasal mandrels from one another by a distance greater than a spacing of the pair of holes in the facepiece mandrel such that a sliding friction occurs between an inner surface of the holes in the facepiece mandrel and an exterior surface of the mouthpiece/nasal mandrels to assist with retaining the facepiece mandrel in engagement with the stop features.
 16. The method according to claim 1, further comprising the step of forming the holes in the facepiece mandrel to have a transverse cross sectional dimension which is greater than a transverse cross sectional dimension of the mouthpiece/nasal mandrels; and affixing a wire to at least a portion of first and second mouthpieces to facilitate adjustable retention of the mouthpieces in aligned positions during use of the cannula.
 17. A nasal and oral cannula having a pair of nares and a pair of mouthpieces with a contiguous flow path between the pair of nares and the pair of mouthpieces, the nasal and oral cannula being manufactured by the method comprising the steps of: assembling a cannula mandrel assembly which comprises separable engageable parts including a facepiece mandrel and a pair of mouthpiece/nasal mandrels, with an intermediate section of the facepiece mandrel being provided with a pair of spaced apart through holes for each receiving a remote free end of one of the mouthpiece/nasal mandrels, by passing the remote free ends of each one of the pair of mouthpiece/nasal mandrels completely through a respective through hole in the facepiece mandrel such that the facepiece mandrel slides along the pair of mouthpiece/nasal mandrels until the through holes of the facepiece mandrel each have an interference fit with a respective larger transverse cross section of the mouthpiece/nasal mandrels, which prevents further sliding movement of the facepiece mandrel, along the pair of mouthpiece/nasal mandrels, while also avoiding flow of a polymeric material between the facepiece mandrel and the mouthpiece/nasal mandrels when applying at least one coating of uncured polymeric material to the cannula mandrel assembly; heating the cannula mandrel assembly to a desired temperature; providing an uncured polymeric material in flowable state; applying at least one coating of the polymeric material to the cannula mandrel assembly to provide a desired material thickness coating on the cannula mandrel assembly; at least partially curing the coating of the polymeric material on the cannula mandrel assembly to form the cannula; disassembling the cannula mandrel assembly by first sliding both the facepiece mandrel and the formed cannula along the mouthpiece/nasal mandrels toward the remote free ends of the mouthpiece/nasal mandrels until the facepiece mandrel and the partially cured cannula are completely removed from the pair of mouthpiece/nasal mandrels; and then withdrawing the facepiece mandrel from the formed cannula. 